GUEST COLUMNISTS

• The Promising Emergence Of Venom-Derived Compounds

  There are 100,000+ venomous animal species, each producing a chemical cocktail of up to 1,000 different components, including peptides, proteins, and non-peptide small molecules. Many in drug development view venom-derived compounds as simple peptides that will be easily digested, limiting their therapeutic potential. This article dispels that myth.

• What’s The Environmental Impact Of Biopharma Continuous Manufacturing? Part I

  One aspect of biopharma continuous manufacturing (BCM) often overlooked is its environmental impact compared to that of a similar batch process. In comparing the two, there is much that needs to be considered. This article is the first in a two-article series and discusses key considerations of both processes and provides a deep-dive into water usage.

• The Promise Of Gene Silencing: A Primer On siRNA

  Small interfering RNAs (siRNAs) are short sequences of RNA that interfere with gene expression, reducing or eliminating the expression of a disease-related protein by targeting its corresponding mRNA. siRNAs could treat a wide array of diseases. How does it differ from other therapeutic modalities such as gene therapy and gene editing?

• Your 3-Step Process For Innovation In Precision Medicine

  Scientific advances are exciting, but not every discovery translates well into the clinic. Why is that? And how can companies successfully position themselves for market success with their drug discovery efforts? 

• Venture Philanthropy For Duchenne Muscular Dystrophy

  This article reviews a number of these advancements and how diseased-focused venture investing can help drive development of next generation therapies.

• Your Guide To Producing ADCs That Meet cGMP Expectations

  Antibody-drug conjugates (ADCs) are a diverse class of biopharmaceuticals that combine highly selective monoclonal antibodies specific to surface antigens present on particular tumor cells. Discussion of current good manufacturing practices (cGMP) in this article includes containment, cleaning and decontamination, and manufacturing and purification.

• Data: The Near Future Of Regulatory Info Management In Europe

  Data, rather than static documents, is the future of regulatory information management. It also paves the way for information to be shared in different formats as use cases dictate, while still ensuring the consistency of the data. Even though regulators haven’t quite got their ducks in a row yet, they know full well that this is the scenario that everything is pointing toward. So, to prepare for anything less would be unwise.

• Heightened Standards For Satisfying Written Description In Pharma Patents

  In Biogen Intl. v. Mylan, the Federal Circuit invalidated claims in one of Biogen’s patents based on its finding that a claimed dosage limitation was insufficiently described in the disclosure and, thus, failed to meet the written description requirement. Between that case and another recent case, the Federal Circuit is showing heightened scrutiny on this patenting subject.